Z-3247-2018Class II

The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including...

Name: Z-3247-2018 The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including...
Creator: Shockwave Medical, Inc.
Published: 2018-07-18
License: https://open.fda.gov/license/

Shockwave Medical, Inc. / initiated 2018-07-18 / Terminated / root cause: manufacturing process

FDA source

Shockwave Medical, Inc. began a recall of The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature... on 2018-07-18. FDA classified it as Class II and gives the reason as "Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3247-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-18
Posted: 2018-09-25
Terminated: 2020-01-22
Recalling firm: Shockwave Medical, Inc.
Product: The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE 0086, STERILE R, Manufacturer: Shockwave Medical, Inc. 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539
Product code: PPN Percutaneous Catheter, Ultrasound
Reason for recall: Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 7/19/2018, the firm sent an Urgent Medical Device Recall Notice to distribution chain/consignees via e-mail informing them that, in some cases, the S4 Peripheral IVL Catheter is not performing as intended. We have seen instances of leaks in the balloon which prevent the balloon from staying inflated at 4 atm for the full course of lithotripsy application. There have been no reports of adverse clinical events related to this issue. This issue does not impact patients who were previously treated with the S4 device. Customers were instructed to discontinue use of all S4 IVL products listed in the recall and place it into quarantine until a Shockwave representative was able to arrange for the S4 IVL product to be returned to Shockwave Medical. The Shockwave representative retrieving the product from the customer is to complete the Acknowledgement and Receipt Form. Recall Contact Nora Hadding Vice President, Quality and Regulatory Affairs Email: [email protected] Phone: 510-279-4262 Monday through Friday, 8:00 AM to 4:30 PM Pacific time.
Quantity in commerce: 612
Distribution: Domestic: CO, TN and TX Foreign: Austria, Germany and New Zealand
Product codes and lots: Catalog No. Part No. Size Lot # UDI (DI Portion Only) S4IVL2540 FG61163-2540 2.50x40mm P180222I M732S4IVL25400 P180327A P180410A P180503A S4IVL3040 FG61163-3040 3.00x40mm P180223A M732S4IVL30400 P180327B P180410B P180503B S4IVL3540 FG61163-3540 3.50x40mm P180223B M732S4IVL35400 P180327C P180410C P180503C S4IVL4040 FG61163-4040 4.00x40mm P180223C M732S4IVL40400 P180327D P180410D P180503D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3247-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3247-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-25

Product code PPN

K180454Class IIShockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc. / cleared 2018-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)